~As of June 2015 data cutoff, in ALK+ NSCLC
patients with prior crizotinib treatment, the confirmed ORR was 62
percent and median PFS was 13.2 months
~In crizotinib-naive ALK+ NSCLC patients, eight
of eight patients had a confirmed response
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced
clinical data on its investigational anaplastic lymphoma kinase
(ALK) inhibitor, brigatinib, were published in The Lancet Oncology
(Gettinger, S.; ed al. The Lancet Onc. 2016, DOI:
10.1016/S1470-2045(16)30392-8 Published 8 November 2016). ARIAD has
submitted a New Drug Application (NDA) for brigatinib to the U.S.
Food and Drug Administration (FDA), seeking U.S. marketing approval
for patients with metastatic ALK-positive (ALK+) non-small cell
lung cancer (NSCLC) who are resistant or intolerant to
crizotinib.
“The publication reports the results of the first clinical
evaluation of brigatinib in patients with advanced malignancies,
including ALK+ NSCLC,” stated Scott N. Gettinger, M.D., associate
professor of medicine at Yale Cancer Center and lead author.
“Brigatinib yielded responses in the majority of patients with
crizotinib-treated ALK+ NSCLC, with median progression free
survival of over one year. Additionally, responses in the brain
were achieved in this crizotinib refractory population. Early onset
pulmonary adverse events, which occurred in eight percent of
patients, generally within 48 hours of first dose, appeared to be
related to starting dose.”
The data published this week include safety analyses on all
patients in the trial (N=137) and efficacy analyses on all patients
with ALK+ NSCLC (n=79). Of the 79 ALK+ NSCLC patients, all but
eight had previously been treated with crizotinib. With patient
data as of June 2015, the median time on treatment for ALK+ NSCLC
patients was 15.4 months (range, 0.03 – 39.4 months, ongoing).
The confirmed objective response rate (ORR) was 62% (44/71) in
ALK+ NSCLC patients with prior crizotinib treatment. The median
progression free survival (PFS) of ALK+ NSCLC patients previously
treated with crizotinib was 13.2 months. Eight ALK+ NSCLC patients
in the trial were crizotinib-naive. Of these, all eight achieved a
confirmed objective response, including three complete responses.
At the time of analysis, median PFS was not reached in these
patients. Brain metastases were identified in 63% of ALK+ NSCLC
patients (50/79) at baseline. The intracranial ORR was 53% (8/15)
among evaluable patients with measurable brain metastases.
The most common grade 3–4 treatment-emergent adverse events
across all doses were increased lipase (9%; 12/137), dyspnea (6%;
8/137), and hypertension (5%; 7/137). Serious treatment-emergent
adverse events (excluding neoplasm progression) reported in ≥5% of
all patients were dyspnea (7%; 10/137), pneumonia (7%; 9/137), and
hypoxia (5%; 7/137). Eight percent of patients (11/137) experienced
a subset of pulmonary adverse events with early onset, most
occurring within 48 hours of dosing. The frequency of these events
appeared dose-related. Among patients who started at 90 mg once
daily and continued at this dose or escalated to 180 mg once daily
after seven days, 2% (1/50) had such events.
Data from the Phase 1/2 trial and pivotal ALTA trial of
brigatinib have been included in the NDA submitted to the FDA. The
FDA has granted ARIAD’s request for Priority Review and has set an
action date of April 29, 2017 under the Prescription Drug User Fee
Act (PDUFA). ARIAD is seeking accelerated U.S. marketing approval
for brigatinib in patients with metastatic ALK+ NSCLC who are
resistant or intolerant to crizotinib and plans to submit a
Marketing Authorization Application (MAA) for brigatinib to the
European Medicines Agency (EMA) in early 2017.
“This in-depth publication provides a thorough review of the
Phase 1/2 trial of brigatinib, ARIAD’s internally developed
targeted cancer candidate under regulatory review,” stated Timothy
P. Clackson, Ph.D., president of research and development and chief
scientific officer at ARIAD. “We are excited to continue to work
with academic collaborators to provide additional clinical detail
on the brigatinib trials, including upcoming presentations at the
World Conference on Lung Cancer in December.”
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD. It is in development for the
treatment of patients with anaplastic lymphoma kinase positive
(ALK+) non-small cell lung cancer (NSCLC). The global Phase 2 ALTA
trial, in patients with locally advanced or metastatic ALK+ NSCLC
who were previously treated with crizotinib, is the primary basis
for brigatinib’s initial regulatory review. ARIAD has also
initiated the Phase 3 ALTA 1L trial to assess the efficacy and
safety of brigatinib in comparison to crizotinib in patients with
locally advanced or metastatic ALK+ NSCLC who have not received
prior treatment with an ALK inhibitor. More information on
brigatinib clinical trials, including the expanded access program
(EAP) for ALK+ NSCLC can be found here.
Brigatinib received Breakthrough Therapy designation from the
FDA for the treatment of patients with ALK+ NSCLC whose tumors are
resistant to crizotinib, and was granted orphan drug designation by
the FDA for the treatment of ALK+ NSCLC.
About ALK+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of
lung cancer, accounting for approximately 85 percent of the
estimated 228,190 new cases of lung cancer diagnosed each year in
the United States, according to the American Cancer Society.
Anaplastic lymphoma kinase (ALK) was first identified as a
chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL).
Genetic studies indicate that chromosomal rearrangements in ALK are
key drivers in a subset of NSCLC patients as well. Approximately
three to eight percent of patients with NSCLC have a rearrangement
in the ALK gene.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
cancers. ARIAD utilizes computational and structural approaches to
design small-molecule drugs that overcome resistance to existing
cancer medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Forward-Looking Statements
This press release contains forward-looking statements. Any
statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding: regulatory
filings for brigatinib and the therapeutic potential of brigatinib
are forward-looking statements which are based on management's
expectations and are subject to certain factors, risks and
uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These factors, risks and uncertainties
include, among others: early-stage clinical data may not be
replicated in later-stage clinical studies; the costs associated
with our research, development, manufacturing and other activities;
the adequacy of our capital resources and the availability of
additional funding; our ongoing and additional clinical trials of
brigatinib may not be successful or initiated, enrolled or
conducted in a timely manner; our ability to meet anticipated
regulatory filing and approval dates for brigatinib; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory and pricing and reimbursement approvals for
brigatinib; competitive risks; manufacturing issues and those
additional factors detailed in our public filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q. Except as otherwise noted, these forward-looking statements
speak only as of the date of this press release and we undertake no
obligation to update or revise any of these statements to reflect
events or circumstances occurring after this press release. We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release. All
forward‐looking statements in this press release are qualified in
their entirety by this cautionary statement.
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version on businesswire.com: http://www.businesswire.com/news/home/20161109005063/en/
ARIAD Pharmaceuticals, Inc.For InvestorsJennifer
Robinson, 617-621-2286jennifer.robinson@ariad.comorFor
MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
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